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Alpha-2 Agonist

Stimulant Medications for ADHD in Autism Spectrum Disorder

Phase 4

Recruiting

Led By Daniel Coury, MD

Research Sponsored by Daniel Coury

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Study Summary

This trial will assess two stimulant medications and a newer type of ADHD medication to help improve medication selection and reduce repeated trials for autistic children and adolescents with ADHD.

Who is the study for?

This trial is for children and adolescents aged 4-17 with both Autism Spectrum Disorder (ASD) and ADHD. They must be able to take medication, have a consistent caregiver, and can be on stable doses of other psychotropic meds. Excluded are those who've had multiple ADHD med trials within the last year or any safety risks.Check my eligibility

What is being tested?

The study tests two stimulant medications—methylphenidate and amphetamine—for treating ADHD in kids with autism. It also examines alpha-2 agonists' effectiveness using a SMART design to potentially streamline medication selection for this group.See study design

What are the potential side effects?

Possible side effects from these medications may include sleep disturbances, decreased appetite, stomachaches, headaches, increased blood pressure or heart rate. Alpha-2 agonists might cause drowsiness or fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Vanderbilt Parent Rating Scale

Secondary outcome measures

Aberrant Behavior Checklist- Hyperactivity/Impulsivity subscale

Parent reported Clinical Global Impression

Trial Design

2Treatment groups

Active Control

Group I: Stage 1 - StimulantActive Control1 Intervention

This proposed naturalistic, pragmatic clinical trial does not involve investigational drugs. Sequential, multiple assignment randomized trial (SMART) pragmatic clinical trial. Stage 1 - randomization to either Amphetamine (AMP) or Methylphenidate (MPH). The specific medication prescribed by the physician will be determined by discussion between physician and parent / caregiver and review of the subject's insurance coverage. Subjects will receive their medication from their pharmacy.

Group II: Stage 2 - Alpha-2 Agonist or Alternate StimulantActive Control1 Intervention

Stage 2 - randomization to either Alpha-2 Agonist or other stimulant not randomized to in Stage 1: Amphetamine (AMP) or Methylphenidate (MPH). (frequency, dosage, format, and duration dependent on participant and study doctor discussion).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MaineHealthOTHER

71 Previous Clinical Trials

48,807 Total Patients Enrolled

University of AlbertaOTHER

889 Previous Clinical Trials

384,634 Total Patients Enrolled

7 Trials studying Autism Spectrum Disorder

1,191 Patients Enrolled for Autism Spectrum Disorder

University of MichiganOTHER

1,798 Previous Clinical Trials

6,377,638 Total Patients Enrolled

9 Trials studying Autism Spectrum Disorder

1,162 Patients Enrolled for Autism Spectrum Disorder

Media Library

Alpha 2 agonist (Alpha-2 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05916339 — Phase 4

Autism Spectrum Disorder Research Study Groups: Stage 1 - Stimulant, Stage 2 - Alpha-2 Agonist or Alternate Stimulant

Autism Spectrum Disorder Clinical Trial 2023: Alpha 2 agonist Highlights & Side Effects. Trial Name: NCT05916339 — Phase 4

Alpha 2 agonist (Alpha-2 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05916339 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I be considered for enrolment in this investigation?

"Potential participants in this autism spectrum disorder clinical trial must be between 4 and 17 years of age. There are 500 available spots for enrolment."

Answered by AI

Has the FDA granted approval for Phase 1 Stimulant?

"The safety of Stage 1 - Stimulant was rated a 3, as the drug is already approved for clinical use and this experiment has reached its fourth phase."

Answered by AI

Are there any notable concentrations of this investigation occurring inside the United States?

"Patients in need of this particular medication can be recruited from Children's Hospital Los Angeles, Maine Medical Center and Massachusetts General Hospital Lurie Centre for Autism as well as 12 other medical facilities."

Answered by AI

Are recruitment efforts ongoing for this experiment?

"According to the clinicaltrials.gov website, this particular investigation is no longer accepting applications and has not been updated since June 14th 2023. Nonetheless, there are currently 436 other trials actively recruiting participants."

Answered by AI

Are minors permitted to take part in the experiment?

"This trial requires participants to be between 4 and 17 years old. Clinicaltrials.gov has 347 studies with this age range, while 69 are available for persons above the retirement age of 65."

Answered by AI